Increasing Adherence to Pulmonary Rehabilitation After COPD Related Hospitalizations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 296
- 试验地点
- 4
- 主要终点
- Adherence to Pulmonary Rehabilitation (PR)
研究概览
简要总结
This study is being done to test the comparative effectiveness of participating in a Pulmonary Rehabilitation Program at home using new technology and health coaching following dismissal from the hospital compared to the referral to a center based pulmonary rehabilitation that may include the choice of center based or telehealth.
详细描述
Despite proven benefits, the proportion of people with COPD who receive Pulmonary Rehabilitation (PR) is very small. The current model of a center-based PR program fails to address the needs of many patients with COPD. After the COVID epidemic, telehealth is an option for individuals referred to patients referred to center based rehabilitation.
The direct referral to home-based, unsupervised PR has been proposed as an alternative model to hospital-based programs and has been found to be safe and effective. The refined home-based PR program from the pilot portion of the study supported by a separate grant mechanism (R61HL142933/NCT03865329) will be tested in this second part randomized control study.
Subjects with a COPD-related hospitalization (exacerbation or pneumonia) will be randomized after hospital discharge to either home-based PR or Choice (referral to conventional center-based PR or home-based PR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD related hospitalization and eligible for PR
- •Confidence (score > 5 in a self-efficacy question (1-10 scale): how confident you feel to use this system on a daily basis)
排除标准
- •- Inability to walk (orthopedic-neurologic problems or confined to bed)
结局指标
主要结局
Adherence to Pulmonary Rehabilitation (PR)
时间窗: baseline; 3 months
The number of subjects who completed PR through 3 months
Change in Health Related Quality of Life as Measured by the Chronic Respiratory Questionnaire (CRQ).
时间窗: baseline; 3 months
The Chronic Respiratory Questionnaire (CRQ) is a validated tool that is completed by participants at baseline and 3 months, measuring health-related quality of life. This questionnaire measures both physical and emotional aspects of chronic respiratory disease. We reported the difference between baseline and 3 months on the CRQ emotional summary scores (comprised of the summation of the mastery and emotional domains of CRQ divided by 2) and the physical summary score (comprised of the summation of the dyspnea and fatigue domains of the CRQ divided by 2). Summary scores as well as the original domains , all have a range of 1 to 7 points, with a higher number being a better health-related quality of life. 0.5 points is the minimal clinically important difference for this tool. Then, for the interpretation of CRQ results: a difference\>0.5 is considered clinically meaningful
Change in EuroQol (EQ-5D) Score
时间窗: baseline; 3 months
The EuroQol (EQ-5D) is a 5-item questionnaire that assesses health-related quality of life over five different dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. It also includes a Visual Analogue Scale (VAS) for self-related heath. Each dimension uses a 5-level Likert scale (1 = no problems, 5 = extreme problems), ensuring nuanced data collection. The VAS ranges from 0 (worst imaginable health) to 100 (best imaginable health). Scores are calculated for each dimension with total scores ranging from 1 (no problems) to 5 (extreme problems), with higher scores indicating a worse outcome. The score from the VAS portion of the questionnaire ranges from 0 (worst imaginable health) to 100 (best imaginable health), with higher scores indicating a better outcome.
次要结局
- Number of Subjects Who Visited the Emergency Department(baseline to 3 months)
- Number of Subjects Who Had a Hospitalization(baseline; 3 months)
- Change in Self-Management Ability Scale(baseline; 3 months)
- Change in Daily Step Count(baseline; 3 months)
- Change in Daily Total Physical Activity and Sedentary Time(Baseline; 3 months)
- Change in Duke-UNC Functional Social Support Questionnaire (FSSQ) Score(baseline; 3 months)
研究者
Roberto P. Benzo
Principal Investigator
Mayo Clinic